Terminologies for coding of adverse reactions and drug information …media.medfarm.uu.se/flvplayer/data/adrrep/video4.pdf · stevens-johnson syndromes STEVEN JOHNSON'S SYNDROME STEVENS-JHONSON

Terminologies for coding of adverse reactions

and drug information

PV Training Course

Uppsala 2-13 May, 2011

Anders Viklund, MSc Pharm

Uppsala Monitoring Centre

Anders Viklund, Uppsala Monitoring Centre

WHO-ARTWHO DDMedDRAICDATCSDG

VigiFlow

ADR report


Purpose & Outline

• To facilitate training in PV tools using terminologies– VigiFlow (input/analysis)

– VigiSearch/VigiMine (analysis)

• Reactions (MedDRA, WHO-ART)

• Drugs (WHO DD, ATC, SDG)

• Relevant medical background (ICD, MedDRA)

• Death causes (ICD-10, MedDRA)

• Diagnosis (ICD-10, MedDRA)10 min

20 min

20 min


An 86-year-old female with bipolar disorder was admitted with anxiety,insomnia, fatigue, and acute renal failure. Although lithium levels were normal,lithium had been discontinued and replaced with carbamazepine100 mg daily 2 days prior to admission. She was also takinghydralazine 100 mg three times daily for hypertension for 2 years withno dosage change in 8 months. On hospital day 8, she developed feverand conjunctivitis followed by oral erosions and painful lesions on her nose,ears, back, and fingers.On examination, she appeared acutely ill and was febrile (38.4°C). Bilateralconjunctivitis with exudative discharge and periorbital edema was noted.Tense vesicles and bullae with surrounding erythema were noted on her scalp,nose, and back. The skin overlying the cartilaginous portions of both ears waserythematous and edematous with focal bullous change.The noncartilaginous lobes appeared normal. Erosions were noted on thehard palate and gingival mucosa. Tender hemorrhagic bullae wereprominent on distal and lateral fingers.Laboratory testing revealed elevated C-reactive protein at 14 mg/dl(normal = 0 to 1 mg/dL) and erythrocyte sedimentation rate of 72 mm/hour(normal = 0 to 17 mm/hour).

Case report in free text








Patient Background Drug ADR Lab test

86-year Bipolar disorder Lithium Fever ElevatedC-reactive protein

female Anxiety Carbamazepine Conjunctivitis High erythrocytesedimentation rate

Insomnia Hydralazine Oral erosions Normal whiteblood cell count

Fatigue Skin lesions Lowhemoglobin

Acute renal failure

Periorbitaledema

Erythema

Hemhorrhagicbullae

Extracted case information


Freedom versus structure

Free text Coded dataComplete representationof complex data

Flexible, expressive, familiar

Computerised retrieval and analysis easy and efficientLanguage independence

Computerised retrieval and analysis difficult

Data entry requirestransformation of theinformation

risk of loss/distortion


A mix between structuredfields and free text boxes

An ADR reporting form


code text 0014001 Erythema multiforme0014003 Erythema annulare0015001 Erythema nodosum0028001 Rash erythematous0028002 Erythema plantar0028003 Erythema0028009 Erythema palmar0042003 Erythema multiforme severe0047006 Application site erythema0080003 Lupus erythematosus discoid

Terminology list

MATCH!

Erythema


code text 0041006 Skin erosion0059003 Auditory meatus external erosion0328009 Erosion gingival1854002 Lip erosion

MATCH!

Oral Erosion

NO MATCH!

Erosion gingival

Oral erosions=

Erosion gingival

National Centre staff


Challenges when using terminologies

STEVENS - JOHNSON SYNDROME STEVEN JOHNSON SYNDROMS

STEVENS JOHSON SYNDROME STEVEN JOHNSON SYNDROME

STEVENS-JOHNSON SYNDROMES STEVEN JOHNSON'S SYNDROME

STEVENS-JHONSON SYNDROME STEVEN JOHNSON SYNDROM

GINGIVAL EROSION PHOTOSENSITIVITY REACTION ALLERGICEROSION GINGIVAL REACTION PHOTOSENSITIVITY ALLERGIC

REACTION ALLERGIC PHOTOSENSITIVITY

SOB, DYSPNOEA, BREATH SHORTNESS

• Synonyms

• Spelling variations

• Word ordering


Terminologies in the WHO ICSR database

WHO-ARTWHO Adverse Reaction Terminology

MedDRAMedical Dictionary for Regulatory Activities

ICDInternational Classification of Diseases

WHO DDWHO Drug Dictionary

ATCAnatomical Therapeutic Chemical classification system


PV tools used by UMC

• VigiFlow™– An ICSR* management system.

– Can be used for both coding and analysing reports

• VigiSearch™/VigiMine™– A search and statistics tool operating on the

WHO global ICSR database, VigiBase™

ICSR = Individual Case Safety Report


VigiFlow Coding Reactions


Use VigiFlow to code this reaction.

VigiFlow Coding ReactionsTASK 1



The VigiFlow reaction coding interface

Hierarchy level

Search type

Submitsearch

Chooselanguage

Entersearch text


VigiFlow Coding ReactionsWHO-ART & MedDRA

• WHO-ART and MedDRA are two terminologies used for coding of reactions.

• Both terminologies are used in the WHO global ICSR database.

• Both terminologies have hierarchical structures


VigiFlow Coding Reactions WHO-ART and MedDRA comparison

MedDRA• Comprehensive - relevant for drug

regulation area and medical information

• Complex – contains also terms not relevant for ADR monitoring

• Easy integration with companies

• Standard terminology in EU, USA, and Japan

• Maintained by the MedDRA-MSSO

WHO-ART• Only for adverse reaction

monitoring. Much smaller in size

• Easy to use, less training needed.

• Developed for spontaneous reporting

• Maintained by the UMC


VigiFlow Coding Reactions Why both MedDRA and WHO-ART

• Some countries/companies have decided to use MedDRA and some WHO-ART when coding ICSRs.

• UMC tools must be able to handle data coded in both MedDRA and WHO-ART since both terminologies are approved in the WHO programme.

• All WHO-ART terms are linked to corresponding MedDRA terms. In a case report both terms are displayed

• All MedDRA terms cannot be linked to a WHO-ART term since MedDRA is much more diverse



System Organ Class32

High level term189

Preferred Term2 178

Included Term3 624

MedDRA 12.0WHO-ART 2011-02-15

System Organ Class26

High level group term333

High level term1 699

Preferred Term18 483

Low Level Term48 676

SOC

HLGT

HLT

PT

LLT

SOC

HLT

PT

IT


VigiFlow Coding Reactions Hierarchy levels

System Organ Class(SOC)

Included Term(IT)

group of preferred terms involving the same body organ

group of similar preferred terms

principal terms for coding and presentation

terms similar topreferred terms

Preferred Term(PT)

High level term(HLT)

High level group term(HLGT)

Low Level Term(LLT)

group of similar high level terms

MedDRAspecific


VigiFlow Coding Reactions Gastric Ulcer


Included Term(IT)

GASTRO-INTESTINAL SYSTEM DISORDERS

Gastric ulcerPreferred Term(PT)


Peptic ulcer

Stomach ulcerUlcus ventriculiPyloric ulcerLarge intestinal ulcerGastric irritationGastrointestinal irritationGastric ulcer helicobacter



VigiFlow browser tree for reactions


VigiFlow Search Reactions


Use VigiFlow to search for this reaction.

VigiFlow Search ReactionsTASK 2



The VigiFlow search and statistics module

Hierarchy level

Search typeSubmitsearch

Chooselanguage

Entersearch text


Browse• Start from a System

Organ Class and drill down to the term you are looking for

• Enter part of or the entire term in the search field and the matching terms appear in a tree structure

QUESTION: Do you know what you are looking for or are you just browsing?

Locate – Search by text





Included Term(IT)

BODY AS A WHOLE

Influenza-like symptomsPreferred Term(PT)


No HL-term

Influenza-like symptomsFlu-like syndrome


VigiFlow Search Reactions Search by text

The VigiFlow reaction browser module


VigiFlow Search Reactions Browse

The VigiFlow reaction browser module

Leave emptyChange to SOC Press search



Please note:

When looking for cases involving “Influenza-like symptoms” – a preferred term;

• The search can be done on System Organ Class level – “Body as a whole” and all cases of interest are retrieved.

• Because “Influenza-like symptoms” is a term included under the SOC “Body as a whole”


VigiSearch/VigiMine Search Reactions


VigiSearch/VigiMine Search ReactionsTASK 3

Use VigiSearch to find cases with this reaction:



Included Term(IT)

GASTRO-INTESTINAL SYSTEM DISORDERS

Gastric ulcerPreferred Term(PT)


Peptic ulcer

Stomach ulcerUlcus ventriculiPyloric ulcerLarge intestinal ulcerGastric irritationGastrointestinal irritationGastric ulcer helicobacter

VigiSearch/VigiMine Search ReactionsGastric Ulcer in WHO-ART


VigiSearch/VigiMine Search ReactionsThe search interface

Choose terminology

Choose level

Add search text


VigiFlow Coding Drugs


VigiFlow Coding DrugsTASK 4

Use VigiFlow to code this drug.

Naprosyn®



The VigiFlow coding interface:

Enter drug name or part of name

Naprosyn



The VigiFlow coding interface:


• A database with information about medicinal products from all over the world– links products with the same ingredients (brands, generics)

– links products containing the same base substance, but different salt/esters

• Information is provided in a consistent and structured way– allows easy and flexible data retrieval and analysis

• It provides useful groupings of data– allows different levels of precision

– useful for both data input and output

• It is continuously updated

VigiFlow Coding DrugsThe WHO Drug Dictionary (WHO-DD)


• The majority of the entries refer to conventional (chemical substance) medicinal products

but the database also includes:

– herbal remedies

– vaccines

– biotech products

– blood products

– diagnostic substances

– contrast media

VigiFlow Coding DrugsTypes of medicinal products in WHO-DD


M01 – Antiinflammatory and antirheumatic products

M01AE – Propionic acid derivatives

M01AE02 - Naproxen

Naprosyn®

Naprosyn®, UK

Naprosyn®, UK, enterotablet, Roche

Naprosyn®, UK, enterotablet, Roche, 250 mg

Therapeutic subgroup

ATC

Naprosyn®, UK, enterotablet

Pharmacological subgroup

Chemical subgroup

Chemical substance, Generic level (ingredients)

Proprietary name (trade name)

Country

Pharmaceutical form

Market Authorization Holder

Strength

Naproxen sodium Salt level

M – Musculo-skeletal system Anatomical main group

M01A – Antiinflammatory and antirheumatic products, non steroids

VigiFlow Coding DrugsThe WHO Drug Dictionary (WHO-DD)


• Which level should I choose?– Choose the level according to the information you have

available

– Tradename level is best. Generic level is good. You can also add an ATC group to describe e.g concomitant medication

– DD is updated continuously, your own national drug reference list is of great importance, if not already implemented. You can also suggest drugs to be added.

• Note: Do not spend time looking for drug information you do not think is important.

VigiFlow Coding DrugsThings to think about


VigiFlow Search Drugs


VigiFlow Search DrugsTASK 4

Use VigiFlow to search for this substance.

fluoxetine


VigiFlow Search Drugs Search by text

VigiFlow Search & Statistics interface:

choose level

enter search text

fluoxetine


N06 – Psychoanaleptics

N06AB – Selective Serotonin Reuptake Inhibitors

N06AB03 - Fluoxetine

Therapeutic subgroup

Pharmacological subgroup

Chemical subgroup

Chemical substance, Generic level (ingredients)

N – Nervous system Anatomical main group

N06A – Antidepressants

VigiFlow Search DrugsThe WHO Drug Dictionary (WHO-DD)



Search results



Please note:

When searching for cases on active substance level you will also include:

• cases where the basefluoxetine is reported

• cases with a reportedfluoxetine salt

• cases with a reported productconnected to the fluoxetine base/salt

Base

Salt

Tradename


VigiFlow Search Drugs Search by browsing (ATC search)


TASK:Find all

SSRI –SelectiveSerotoninReuptakeInhibitors


VigiFlow Search DrugsAnatomical Therapeutic Chemical

classification system (ATC)

• The ATC classification is issued by the WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway

• Medicinal products are classified according to the main therapeutic use in 14 different groups (see previous slide)

• Each group is divided into five levels (e.g. Nervous system group)

N06 – Psychoanaleptics

N06AB – Selective Serotonin Reuptake Inhibitors

N06AB03 - Fluoxetine

2nd level - Therapeutic subgroup

3rd level - Pharmacological subgroup

4th level - Chemical subgroup

5th level - Chemical substance

N – Nervous system 1st level - Anatomical main group

N06A – Antidepressants


VigiFlow Search Drugs Search by browsing (ATC search)


7 more …


VigiSearch/Vigimine Search Drugs


VigiSearch/VigiMine Search DrugsTASK 5

Use VigiSearch to search for this drug.

fluoxetine


VigiSearch/VigiMine Search Drugs Search by text

VigiSearch query interface:

choose level enter search text

fluoxetine


VigiSearch/VigiMine Search Drugs Search by text



VigiSearch/VigiMine Search Drugs Search by browsing


Task: Find all SSRIs

choose level ATCpress magnifier


VigiSearch/VigiMine Search Drugs Search by browsing


• ATC groups and Substance (generic level) are usual in search criteria.

• VigiSearch/VigiMine is more optimized for browsing than VigiFlow Search & Statistics

• In VigiFlow you can also add product country and market authorization holder.

Analysis DrugsAbout drug analysis in VigiSearch/Vigimine and VigiFlow


VigiFlow Coding Usage ofInternational Classification of Diseases (ICD)


• The ICD is the international standard diagnostic classification for all general epidemiological, many health management purposes and clinical use

• It is used to classify diseases and other health problems recorded on many types of health and vital records including death certificates and health records

• Maintained by WHO in Geneva.

VigiFlow Coding ICDThe International Classification of Diseases


• Patient– Death related information

• Relevant Medical History

• Relevant Past Drug Theraphy– Theraphy

• Drugs– Indication

• Assessment– Sender’s diagnosis

VigiFlow Coding ICDUsage of ICD in VigiFlow


VigiFlow Coding ICDUsage of ICD in VigiFlow


VigiFlow Coding ICDICD Hierarchy 1st level

VI G00-G99 Diseases of the nervous system


VigiFlow Coding ICDICD Hierarchy 2nd level


VigiFlow Coding ICDICD Hierarchy 3rd level


VigiFlow Coding ICDICD Hierarchy 4th level


Terminologies are crucial

• Store incoming data in a structured way

• Find related data and patterns

• Analyse big datasets

• International collaboration and communication concerning issues and new knowledge in Pharmacovigilance

Documents

Terminologies for coding of adverse reactions and drug information …media.medfarm.uu.se/flvplayer/data/adrrep/video4.pdf · stevens-johnson syndromes STEVEN JOHNSON'S SYNDROME STEVENS-JHONSON